Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption(1), and in particular Article 3(3)(a) thereof,

10.1.2009 | EN | Official Journal of the European Union | L 6/20 ---|---|---|--- * * * COMMISSION DIRECTIVE 2008/128/EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs (Codified version) (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof, Whereas: (1) | Commission Directive 95/45/EC of 26 July 1995 laying down specific criteria concerning colours for use in foodstuffs (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Directive should be codified. ---|--- (2) | It is necessary to establish purity criteria for all colours mentioned in European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs (4). ---|--- (3) | It is necessary to take into account the specifications and analytical techniques for colours as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). ---|--- (4) | Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria. ---|--- (5) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health. ---|--- (6) | This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B, ---|--- HAS ADOPTED THIS DIRECTIVE: Article 1 The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for colours mentioned in Directive 94/36/EC are set out in Annex I hereto. Article 2 Directive 95/45/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III. Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States. Done at Brussels, 22 December 2008. For the Commission The President José Manuel BARROSO * * * (1) OJ L 40, 11.2.1989, p. 27. (2) OJ L 226, 22.9.1995, p. 1. (3) See Annex II, Part A. (4) OJ L 237, 10.9.1994, p. 13. * * * ANNEX I A. GENERAL SPECIFICATIONS FOR ALUMINIUM LAKES OF COLOURS Definition | Aluminium lakes are prepared by reacting colours complying with the purity criteria set out in the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually freshly prepared undried material made by reacting aluminium sulfate or chloride with sodium or calcium carbonate or bicarbonate or ammonia. Following lake formation, the product is filtered, washed with water and dried. Unreacted alumina may also be present in the finished product. ---|--- HCl insoluble matter | Not more than 0,5 % Ether extractable matter | Not more than 0,2 % (under neutral conditions) Specific purity criteria for the corresponding colours are applicable. B. SPECIFIC CRITERIA OF PURITY E 100 CURCUMIN --- Synonyms | CI Natural Yellow 3, Turmeric Yellow, Diferoyl Methane Definition | Curcumin is obtained by solvent extraction of turmeric i.e. the ground rhizomes of natural strains of Curcuma longa L. In order to obtain a concentrated curcumin powder, the extract is purified by crystallisation. The product consists essentially of curcumins; i.e. the colouring principle (1,7-bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-dien-3,5-dione) and its two desmethoxy derivatives in varying proportions. Minor amounts of oils and resins naturally occuring in turmeric may be present. Only the following solvents may be used in the extraction: ethylacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane. Class | Dicinnamoylmethane Colour Index No | 75300 Einecs | 207-280-5 Chemical names | | I | 1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione ---|--- II | 1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dione ---|--- III | 1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione ---|--- Chemical formula | | I | C21H20O6 ---|--- II | C20H18O5 ---|--- III | C19H16O4 ---|--- Molecular weight | | I. | 368,39 ---|--- II. | 338,39 ---|--- III. | 308,39 ---|--- Assay | Content not less than 90 % total colouring matters E1 cm 1 %1 607 at ca 426 nm in ethanol Description | Orange-yellow crystalline powder Identification | A. | Spectrometry ---|--- Maximum in ethanol at ca 426 nm | B. | Melting Range ---|--- 179 °C-182 °C Purity Solvent residues | Ethylacetate Acetone n-butanol Methanol Ethanol Hexane | Not more than 50 mg/kg, singly or in combination Dichloromethane: not more than 10 mg/kg Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 101 (i) RIBOFLAVIN Synonyms | Lactoflavin Class | Isoalloxazine Einecs | 201-507-1 Chemical names | 7,8-Dimethyl-10-(D-ribo-2,3,4,5-tetrahydroxypentyl)benzo(g)pteridine-2,4(3H,10H)-dione 7,8-dimethyl-10-(1′-D-ribityl)isoalloxazine Chemical formula | C17H20N4O6 Molecular weight | 376,37 Assay | Content not less than 98 % on the anhydrous basis E1 cm 1 % 328 at ca 444 nm in aqueous solution Description | Yellow to orange-yellow crystalline powder, with slight odour Identification | A. | Spectrometry ---|--- The ratio A375/A267 is between 0,31 and 0,33 The ratio A444/A267 is between 0,36 and 0,39 | in aqueous solution Maximum in water at ca 444 nm | B. | Specific rotation ---|--- [α]D20 between – 115° and – 140° in a 0,05 N sodium hydroxide solution Purity Loss on drying | Not more than 1,5 % after drying at 105 °C for 4 hrs Sulfated ash | Not more than 0,1 % Primary aromatic amines | Not more than 100 mg/kg (calculated as aniline) Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 101 (ii) RIBOFLAVIN-5′-PHOSPHATE Synonyms | Riboflavin-5′-phosphate sodium Definition | These specifications apply to riboflavin 5′-phosphate together with minor amounts of free riboflavin and riboflavin diphosphate Class | Isoalloxazine Einecs | 204-988-6 Chemical names | Monosodium (2R,3R,4S)-5-(3′)10′-dihydro-7′,8′-dimethyl-2′,4′-dioxo-10′-benzo[γ]pteridinyl)-2,3,4-trihydroxypentyl phosphate; monosodium salt of 5′-monophosphate ester of riboflavin Chemical formula | | For the dihydrate form | : | C17H20N4NaO9P·2H2O ---|---|--- For the anhydrous form | : | C17H20N4NaO9P Molecular weight | 541,36 Assay | Content not less than 95 % total colouring matters calculated as C17H20N4NaO9P·2H2O E1 cm 1 % 250 at ca 375 nm in aqueous solution Description | Yellow to orange crystalline hygroscopic powder, with slight odour and a bitter taste Identification | A. | Spectrometry ---|--- The ratio A375/A267 is between 0,30 and 0,34 The ratio A444/A267 is between 0,35 and 0,40 | in aqueous solution Maximum in water at ca 444 nm | B. | Specific rotation ---|--- [α]D20 between + 38° and + 42° in a 5 molar HCl solution Purity Loss on drying | Not more than 8 % (100 °C, 5 hrs in vacuum over P2O5) for the dihydrate form Sulfated ash | Not more than 25 % Inorganic phosphate | Not more than 1,0 % (calculated as PO4 on the anhydrous basis) Subsidiary colouring matters | | Riboflavin (free) | : | Not more than 6 % ---|---|--- Riboflavine diphosphate | : | Not more than 6 % Primary aromatic amines | Not more than 70 mg/kg (calculated as aniline) Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 102 TARTRAZINE Synonyms | CI Food Yellow 4 Definition | Tartrazine consists essentially of trisodium 5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Tartrazine is described as the sodium salt. The calcium and the potassium salt are also permitted. Class | Monoazo Colour Index No | 19140 Einecs | 217-699-5 Chemical names | Trisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate Chemical formula | C16H9N4Na3O9S2 Molecular weight | 534,37 Assay | Content not less than 85 % total colouring matters calculated as the sodium salt E1 cm 1 % 530 at ca 426 nm in aqueous solution Description | Light orange powder or granules Identification | A. | Spectrometry ---|--- Maximum in water at ca 426 nm | B. | Yellow solution in water ---|--- Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Not more than 1,0 % Organic compounds other than colouring matters: | | | 4-hydrazinobenzene sulfonic acid ---|--- | 4-aminobenzene-1-sulfonic acid ---|--- | 5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid ---|--- | 4,4′-diazoaminodi(benzene sulfonic acid) ---|--- | Tetrahydroxysuccinic acid ---|--- Total not more than 0,5 % Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) Ether extractable matter | Not more than 0,2 % under neutral conditions Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 104 QUINOLINE YELLOW Synonyms | CI Food Yellow 13 Definition | Quinoline Yellow is prepared by sulfonating 2-(2-quinolyl) indan-1,3-dione. Quinoline Yellow consists essentially of sodium salts of a mixture of disulfonates (principally), monosulfonates and trisulfonates of the above compound and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Quinoline Yellow is described as the sodium salt. The calcium and the potassium salt are also permitted. Class | Chinophthalone Colour Index No | 47005 Einecs | 305-897-5 Chemical name | The disodium salts of the disulfonates of 2-(2-quinolyl) indan-1,3-dione (principal component) Chemical formula | C18H9N Na2O8S2 (principal component) Molecular weight | 477,38 (principal component) Assay | Content not less than 70 % total colouring matters calculated as the sodium salt Quinoline Yellow shall have the following composition: Of the total colouring matters present: | — | not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates ---|--- — | not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates ---|--- — | not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate ---|--- E1 cm 1 % 865 (principal component) at ca 411 nm in aqueous acetic acid solution Description | Yellow powder or granules Identification | A. | Spectrometry ---|--- Maximum in aqueous acetic acid solution of pH 5 at ca 411 nm | B. | Yellow solution in water ---|--- Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Not more than 4,0 % Organic compounds other than colouring matters: | | | 2-methylquinoline ---|--- | 2-methylquinoline-sulfonic acid ---|--- | Phthalic acid ---|--- | 2,6-dimethyl quinoline ---|--- | 2,6-dimethyl quinoline sulfonic acid ---|--- Total not more than 0,5 % 2-(2-quinolyl)indan-1,3-dione | Not more than 4 mg/kg Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) Ether extractable matter | Not more than 0,2 % under neutral conditions Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 110 SUNSET YELLOW FCF Synonyms | CI Food Yellow 3, Orange Yellow S Definition | Sunset Yellow FCF consists essentially of disodium 2-hydroxy-1-(4-sulfonatophenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted. Class | Monoazo Colour Index No | 15985 Einecs | 220-491-7 Chemical names | Disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate Chemical formula | C16H10N2Na2O7S2 Molecular weight | 452,37 Assay | Content not less than 85 % total colouring matters calculated as the sodium salt E1 cm 1 % 555 at ca 485 nm in aqueous solution at pH 7 Description | Orange-red powder or granules Identification | A. | Spectrometry ---|--- Maximum in water at ca 485 nm at pH 7 | B. | Orange solution in water ---|--- Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Not more than 5,0 % 1-(Phenylazo)-2-naphthalenol (Sudan I) | Not more than 0,5 mg/kg Organic compounds other than colouring matters: | | | 4-aminobenzene-1-sulfonic acid ---|--- | 3-hydroxynaphthalene-2,7-disulfonic acid ---|--- | 6-hydroxynaphthalene-2-sulfonic acid ---|--- | 7-hydroxynaphthalene-1,3-disulfonic acid ---|--- | 4,4′-diazoaminodi(benzene sulfonic acid) ---|--- | 6,6′-oxydi(naphthalene-2-sulfonic acid) ---|--- Total not more than 0,5 % Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) Ether extractable matter | Not more than 0,2 % under neutral conditions Arsenic | Not more than 3 mg/kg Lead | Not more than 2 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg E 120 COCHINEAL, CARMINIC ACID, CARMINES Definition | Carmines and carminic acid are obtained from aqueous, aqueous alcoholic or alcoholic extracts from Cochineal, which consists of the dried bodies of the female insect Dactylopius coccus Costa. The colouring principle is carminic acid. Aluminium lakes of carminic acid (carmines) can be formed in which aluminium and carminic acid are thought to be present in the molar ratio 1:2. In commercial products the colouring principle is present in association with ammonium, calcium, potassium or sodium cations, singly or in combination, and these cations may also be present in excess. Commercial products may also contain proteinaceous material derived from the source insect, and may also contain free carminate or a small residue of unbound aluminium cations. Class | Anthraquinone Colour Index No | 75470 Einecs | Cochineal: 215-680-6; carminic acid: 215-023-3; carmines: 215-724-4 Chemical names | 7-β-D-glucopyranosyl-3,5,6,8-tetrahydroxy-1-methyl-9,10-dioxoanthracene-2-carboxylic acid (carminic acid); carmine is the hydrated aluminium chelate of this acid Chemical formula | C22H20O13 (carminic acid) Molecular weight | 492,39 (carminic acid) Assay | Content not less than 2,0 % carminic acid in the extracts containing carminic acid; not less than 50 % carminic acid in the chelates. Description | Red to dark red, friable, solid or powder. Cochineal extract is generally a dark red liquid but can also be dried as a powder. Identification Spectrometry | Maximum in aqueous ammonia solution at ca 518 nm Maximum in dilute hydrochloric solution at ca 494 nm for carminic acid Purity Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 122 AZORUBINE, CARMOISINE Synonyms | CI Food Red 3 Definition | Azorubine consists essentially of disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Azorubine is described as the sodium salt. The calcium and the potassium salt are also permitted. Class | Monoazo Colour Index No | 14720 Einecs | 222-657-4 Chemical name | Disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate Chemical formula | C20H12N2Na2O7S2 Molecular weight | 502,44 Assay | Content not less than 85 % total colouring matters, calculated as the sodium salt E1 cm 1 % 510 at ca 516 nm in aqueous solution Description | Red to maroon powder or granules Identification | A. | Spectrometry ---|--- Maximum in water at ca 516 nm | B. | Red solution in water ---|--- Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Not more than 2,0 % Organic compounds other than colouring matters: | | | 4-aminonaphthalene-1-sulfonic acid ---|--- | 4-hydroxynaphthalene-1-sulfonic acid ---|--- Total not more than 0,5 % Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) Ether extractable matter | Not more than 0,2 % under neutral conditions Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 123 AMARANTH Synonyms | CI Food Red 9 Definition | Amaranth consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Amaranth is described as the sodium salt. The calcium and the potassium salt are also permitted. Class | Monoazo Colour Index No | 16185 Einecs | 213-022-2 Chemical name | Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate Chemical formula | C20H11N2Na3O10S3 Molecular weight | 604,48 Assay | Content not less than 85 % total colouring matters, calculated as the sodium salt E1 cm 1 % 440 at ca 520 nm in aqueous solution Description | Reddish-brown powder or granules Identification | A. | Spectrometry ---|--- Maximum in water at ca 520 nm | B. | Red solution in water ---|--- Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Not more than 3,0 % Organic compounds other than colouring matters: | | | 4-aminonaphthalene-1-sulfonic acid ---|--- | 3-hydroxynaphthalene-2,7-disulfonic acid ---|--- | 6-hydroxynaphthalene-2-sulfonic acid ---|--- | 7-hydroxynaphthalene-1,3-disulfonic acid ---|--- | 7-hydroxynaphthalene-1,3-6-trisulfonic acid ---|--- Total not more than 0,5 % Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) Ether extractable matter | Not more than 0,2 % under neutral conditions Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 124 PONCEAU 4R, COCHINEAL RED A Synonyms | CI Food Red 7, New Coccine Definition | Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Ponceau 4R is described as the sodium salt. The calcium and the potassium salt are also permitted. Class | Monoazo Colour Index No | 16255 Einecs | 220-036-2 Chemical name | Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate Chemical formula | C20H11N2Na3O10S3 Molecular weight | 604,48 Assay | Content not less than 80 % total colouring matters, calculated as the sodium salt. E1 cm 1 % 430 at ca 505 nm in aqueous solution Description | Reddish powder or granules Identification | A. | Spectrometry ---|--- Maximum in water at ca 505 nm | B. | Red solution in water ---|--- Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Not more than 1,0 % Organic compounds other than colouring matters: | | | 4-aminonaphthalene-1-sulfonic acid ---|--- | 7-hydroxynaphthalene-1,3-disulfonic acid ---|--- | 3-hydroxynaphthalene-2,7-disulfonic acid ---|--- | 6-hydroxynaphthalene-2-sulfonic acid ---|--- | 7-hydroxynaphthalene-1,3-6-trisulfonic acid ---|--- Total not more than 0,5 % Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) Ether extractable matter | Not more than 0,2 % under neutral conditions Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 127 ERYTHROSINE Synonyms | CI Food Red 14 Definition | Erythrosine consists essentially of disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl) benzoate monohydrate and subsidiary colouring matters together with water, sodium chloride and/or sodium sulfate as the principal uncoloured components. Erythrosine is described as the sodium salt. The calcium and the potassium salt are also permitted. Class | Xanthen Colour Index No | 45430 Einecs | 240-474-8 Chemical name | Disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl)benzoate monohydrate Chemical formula | C20H6I4Na2O5.H2O Molecular weight | 897,88 Assay | Content not less than 87 % total colouring matters, calculated as the anhydrous sodium salt E1 cm 1 %1 100 at ca 526 nm in aqueous solution at pH 7 Description | Red powder or granules. Identification | A. | Spectrometry ---|--- Maximum in water at ca 526 nm at pH 7 | B. | Red solution in water ---|--- Purity Inorganic iodides calculated as sodium iodide | Not more than 0,1 % Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters (except fluorescein) | Not more than 4,0 % Fluorescein | Not more than 20 mg/kg Organic compounds other than colouring matters: | Tri-iodoresorcinol | Not more than 0,2 % 2-(2,4-dihydroxy-3,5-diodobenzoyl) benzoic acid | Not more than 0,2 % Ether extractable matter | From a solution of pH from 7 through 8, not more than 0,2 % Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg Aluminium Lakes | The hydrochloric acid insoluble matter method is not applicable. It is replaced by a sodium hydroxide insoluble matter, at not more than 0,5 %, for this colour only. E 128 RED 2G Synonyms | CI Food Red 10, Azogeranine Definition | Red 2G consists essentially of disodium 8-acetamido-1-hydroxy-2-phenylazonaphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Red 2G is described as the sodium salt. The calcium and the potassium salt are also permitted. Class | Monoazo Colour Index No | 18050 Einecs | 223-098-9 Chemical name | Disodium 8-acetamido-1-hydroxy-2-phenylazo-naphthalene-3,6-disulfonate Chemical formula | C18H13N3Na2O8S2 Molecular weight | 509,43 Assay | Content not less than 80 % total colouring matters, calculated as the sodium salt E1 cm 1 % 620 at ca 532 nm in aqueous solution Description | Red powder or granules Identification | A. | Spectrometry ---|--- Maximum in water at ca 532 nm | B. | Red solution in water ---|--- Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Not more than 2,0 % Organic compounds other than colouring matters: | | | 5-acetamido-4-hydroxynaphthalene-2,7-disulfonic acid ---|--- | 5-amino-4-hydroxynaphthalene-2,7-disulfonic acid ---|--- Total not more than 0,5 % Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) Ether extractable matter | Not more than 0,2 % under neutral conditions Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 129 ALLURA RED AC Synonyms | CI Food Red 17 Definition | Allura Red AC consists essentially of disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonato-phenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Allura Red AC is described as the sodium salt. The calcium and the potassium salt are also permitted. Class | Monoazo Colour Index No | 16035 Einecs | 247-368-0 Chemical name | Disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo) naphthalene-6-sulfonate Chemical formula | C18H14N2Na2O8S2 Molecular weight | 496,42 Assay | Content not less than 85 % total colouring matters, calculated as the sodium salt E1 cm 1 % 540 at ca 504 nm in aqueous solution at pH 7 Description | Dark red powder or granules Identification | A. | Spectrometry ---|--- Maximum in water at ca 504 nm | B. | Red solution in water ---|--- Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Not more than 3,0 % Organic compounds other than colouring matters: | 6-hydroxy-2-naphthalene sulfonic acid, sodium salt | Not more than 0,3 % 4-amino-5-methoxy-2-methylbenezene sulfonic acid | Not more than 0,2 % 6,6-oxybis (2-naphthalene sulfonic acid) disodium salt | Not more than 1,0 % Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) Ether extractable matter | From a solution of pH 7, not more than 0,2 % Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 131 PATENT BLUE V Synonyms | CI Food Blue 5 Definition | Patent Blue V consists essentially of the calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene)2,5-cyclohexadien-1-ylidene] diethylammonium hydroxide inner salt and subsidiary colouring matters together with sodium chloride and/or sodium sulfate and/or calcium sulfate as the principal uncoloured components. The potassium salt is also permitted. Class | Triarylmethane Colour Index No | 42051 Einecs | 222-573-8 Chemical names | The calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene) 2,5-cyclohexadien-1-ylidene] diethyl-ammonium hydroxide inner salt Chemical formula | Calcium compound: C27H31N2O7S2Ca Sodium compound: C27H31N2O7S2Na Molecular weight | Calcium compound: 579,72 Sodium compound: 582,67 Assay | Content not less than 85 % total colouring matters, calculated as the sodium salt E1 cm 1 %2 000 at ca 638 nm in aqueous solution at pH 5 Description | Dark-blue powder or granules Identification | A. | Spectrometry ---|--- Maximum in water at 638 nm at pH 5 | B. | Blue solution in water ---|--- Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Not more than 2,0 % Organic compounds other than colouring matters: | | | 3-hydroxy benzaldehyde ---|--- | 3-hydroxy benzoic acid ---|--- | 3-hydroxy-4-sulfobenzoic acid ---|--- | N,N-diethylamino benzene sulfonic acid ---|--- Total not more than 0,5 % Leuco base | Not more than 4,0 % Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) Ether extractable matter | From a solution of pH 5 not more than 0,2 % Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 132 INDIGOTINE, INDIGO CARMINE Synonyms | CI Food Blue 1 Definition | Indigotine consists essentially of a mixture of disodium 3,3′dioxo-2,2′-bi-indolylidene-5,5′-disulfonate, and disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Indigotine is described as the sodium salt. The calcium and the potassium salt are also permitted. Class | Indigoid Colour Index No | 73015 Einecs | 212-728-8 Chemical names | Disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,5′-disulfonate Chemical formula | C16H8N2Na2O8S2 Molecular weight | 466,36 Assay | Content not less than 85 % total colouring matters, calculated as the sodium salt; disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 18 % E1 cm 1 % 480 at ca 610 nm in aqueous solution Description | Dark-blue powder or granules Identification | A. | Spectrometry ---|--- Maximum in water at ca 610 nm | B. | Blue solution in water ---|--- Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Excluding disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 1,0 % Organic compounds other than colouring matters: | | | Isatin-5-sulfonic acid ---|--- | 5-sulfoanthranilic acid ---|--- | Anthranilic acid ---|--- Total not more than 0,5 % Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) Ether extractable matter | Not more than 0,2 % under neutral conditions Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 133 BRILLIANT BLUE FCF Synonyms | CI Food Blue 2 Definition | Brilliant Blue FCF consists essentially of disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate and its isomers and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Brilliant Blue FCF is described as the sodium salt. The calcium and the potassium salt are also permitted. Class | Triarylmethane Colour Index No | 42090 Einecs | 223-339-8 Chemical names | Disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate Chemical formula | C37H34N2Na2O9S3 Molecular weight | 792,84 Assay | Content not less than 85 % total colouring matters, calculated as the sodium salt E1 cm 1 %1 630 at ca 630 nm in aqueous solution Description | Reddish-blue powder or granules Identification | A. | Spectrometry ---|--- Maximum in water at ca 630 nm | B. | Blue solution in water ---|--- Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Not more than 6,0 % Organic compounds other than colouring matters: | Sum of 2-, 3- and 4-formyl benzene sulfonic acids | Not more than 1,5 % 3-((ethyl)(4-sulfophenyl) amino) methyl benzene sulfonic acid | Not more than 0,3 % Leuco base | Not more than 5,0 % Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) Ether extractable matter | Not more than 0,2 % at pH 7 Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 140 (i) CHLOROPHYLLS Synonyms | CI Natural Green 3, Magnesium Chlorophyll, Magnesium Phaeophytin Definition | Chlorophylls are obtained by solvent extraction of natural strains of edible plant material, grass, lucerne and nettle. During the subsequent removal of solvent, the naturally present co-ordinated magnesium may be wholly or partly removed from the chlorophylls to give the corresponding phaeophytins. The principal colouring matters are the phaeophytins and magnesium chlorophylls. The extracted product, from which the solvent has been removed, contains other pigments such as carotenoids as well as oils, fats and waxes derived from the source material. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane. Class | Porphyrin Colour Index No | 75810 Einecs | Chlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4 Chemical names | The major colouring principles are: | | Phytyl (132 R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate, (Pheophytin a), or as the magnesium complex (Chlorophyll a) ---|--- | Phytyl (132 R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b) ---|--- Chemical formula | Chlorophyll a (magnesium complex): C55H72MgN4O5 Chlorophyll a: C55H74N4O5 Chlorophyll b (magnesium complex): C55H70MgN4O6 Chlorophyll b: C55H72N4O6 Molecular weight | Chlorophyll a (magnesium complex): 893,51 Chlorophyll a: 871,22 Chlorophyll b (magnesium complex): 907,49 Chlorophyll b: 885,20 Assay | Content of total combined Chlorophylls and their magnesium complexes is not less than 10 % E1 cm 1 % 700 at ca 409 nm in chloroform Description | Waxy solid ranging in colour from olive green to dark green depending on the content of co-ordinated magnesium Identification Spectrometry | Maximum in chloroform at ca 409 nm Purity Solvent residues | Acetone Methyl Ethyl ketone Methanol Ethanol Propan-2-ol Hexane | Not more than 50 mg/kg, singly or in combination Dichloromethane: Not more than 10 mg/kg Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 140 (ii) CHLOROPHYLLINS Synonyms | CI Natural Green 5, Sodium Chlorophyllin, Potassium Chlorophyllin Definition | The alkali salts of chlorophyllins are obtained by the saponification of a solvent extract of natural strains of edible plant material, grass, lucerne and nettle. The saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. The acid groups are neutralized to form the salts of potassium and/or sodium. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane. Class | Porphyrin Colour Index No | 75815 Einecs | 287-483-3 Chemical names | The major colouring principles in their acid forms are: | — | 3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin a) and ---|--- — | 3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin b) ---|--- Depending on the degree of hydrolysis the cyclopentenyl ring may be cleaved with the resultant production of a third carboxyl function. Magnesium complexes may also be present. Chemical formula | Chlorophyllin a (acid form): C34H34N4O5 Chlorophyllin b (acid form): C34H32N4O6 Molecular weight | Chlorophyllin a: 578,68 Chlorophyllin b: 592,66 Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved. Assay | Content of total chlorophyllins is not less than 95 % of the sample dried at ca 100 °C for 1 hour. E1 cm 1 % 700 at ca 405 nm in aqueous solution at pH 9 E1 cm 1 % 140 at ca 653 nm in aqueous solution at pH 9 Description | Dark green to blue/black powder Identification Spectrometry | Maximum in aqueous phosphate buffer at pH 9 at ca 405 nm and at ca 653 nm Purity Solvent residues | Acetone Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane | Not more than 50 mg/kg, singly or in combination Dichloromethane: not more than 10 mg/kg Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 141 (i) COPPER COMPLEXES OF CHLOROPHYLLS Synonyms | CI Natural Green 3, Copper Chlorophyll, Copper Phaeophytin Definition | Copper chlorophylls are obtained by addition of a salt of copper to the substance obtained by solvent extraction of natural strains of edible plant material, grass, lucerne, and nettle. The product, from which the solvent has been removed, contains other pigments such as carotenoids as well as fats and waxes derived from the source material. The principal colouring matters are the copper phaeophytins. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane. Class | Porphyrin Colour Index No | 75815 Einecs | Copper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5 Chemical names | [Phytyl (132 R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper Chlorophyll a) [Phytyl (132 R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper chlorophyll b) Chemical formula | Copper chlorophyll a: C55H72Cu N4O5 Copper chlorophyll b: C55H70Cu N4O6 Molecular weight | Copper chlorophyll a: 932,75 Copper chlorophyll b: 946,73 Assay | Content of total copper chlorophylls is not less than 10 %. E1 cm 1 % 540 at ca 422 nm in chloroform E1 cm 1 % 300 at ca 652 nm in chloroform Description | Waxy solid ranging in colour from blue green to dark green depending on the source material Identification Spectrometry | Maximum in chloroform at ca 422 nm and at ca 652 nm Purity Solvent residues | Acetone Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane | Not more than 50 mg/kg, singly or in combination Dichloromethane: not more than 10 mg/kg Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Copper ions | Not more than 200 mg/kg Total copper | Not more than 8,0 % of the total copper phaeophytins E 141 (ii) COPPER COMPLEXES OF CHLOROPHYLLINS Synonyms | Sodium Copper Chlorophyllin, Potassium Copper Chlorophyllin, CI Natural Green 5 Definition | The alkali salts of copper chlorophyllins are obtained by the addition of copper to the product obtained by the saponification of a solvent extraction of natural strains of edible plant material, grass, lucerne, and nettle; the saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. After addition of copper to the purified chlorophyllins, the acid groups are neutralized to form the salts of potassium and/or sodium. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide methanol, ethanol, propan-2-ol and hexane. Class | Porphyrin Colour Index No | 75815 Einecs | Chemical names | The major colouring principles in their acid forms are: 3-(10-Carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate, copper complex (Copper chlorophyllin a) and 3-(10-Carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl) propionate, copper complex (Copper chlorophyllin b) Chemical formula | Copper chlorophyllin a (acid form): C34H32Cu N4O5 Copper chlorophyllin b (acid form): C34H30Cu N4O6 Molecular weight | Copper chlorophyllin a: 640,20 Copper chlorophyllin b: 654,18 Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved. Assay | Content of total copper chlorophyllins is not less than 95 % of the sample dried at 100 °C for 1 h. E1 cm 1 % 565 at ca 405 nm in aqueous phosphate buffer at pH 7,5 E1 cm 1 % 145 at ca 630 nm in aqueous phosphate buffer at pH 7,5 Description | Dark green to blue/black powder Identification Spectrometry | Maximum in aqueous phosphate buffer at pH 7,5 at ca 405 nm and at ca 630 nm Purity Solvent residues | Acetone Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane | Not more than 50 mg/kg, singly or in combination Dichloromethane: not more than 10 mg/kg Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Copper ions | Not more than 200 mg/kg Total copper | Not more than 8,0 % of the total copper chlorophyllins E 142 GREEN S Synonyms | CI Food Green 4, Brilliant Green BS Definition | Green S consists essentially of sodium N-[4-(dimethylamino)phenyl] 2-hydroxy-3,6-disulfo-1-naphthalenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured compounds. Green S is described as the sodium salt. The calcium and the potassium salt are also permitted. Class | Triarylmethane Colour Index No | 44090 Einecs | 221-409-2 Chemical names | Sodium N-[4-[[4-(dimethylamino)phenyl](2-hydroxy-3,6-disulfo-1-naphthalenyl)-methylene]2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium; Sodium 5-[4-dimethylamino-α-(4-dimethyliminocyclohexa-2,5-dienylidene) benzyl]-6-hydroxy-7-sulfonato-naphthalene-2-sulfonate (alternative chemical name). Chemical formula | C27H25N2NaO7S2 Molecular Weight | 576,63 Assay | Content not less than 80 % total colouring matters calculated as the sodium salt E1 cm 1 %1 720 at ca 632 nm in aqueous solution Description | Dark blue or dark green powder or granules Identification | A. | Spectrometry ---|--- Maximum in water at ca 632 nm | B. | Blue or green solution in water ---|--- Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Not more than 1,0 % Organic compounds other than colouring matters: | 4,4′-bis(dimethylamino)-benzhydryl alcohol | Not more than 0,1 % 4,4′-bis(dimethylamino)-benzophenone | Not more than 0,1 % 3-hydroxynaphthalene-2,7-disulfonic acid | Not more than 0,2 % Leuco base | Not more than 5,0 % Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) Ether extractable matter | Not more than 0,2 % under neutral conditions Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 150a PLAIN CARAMEL Definition | Plain caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose). To promote caramelization, acids, alkalis and salts may be employed, with the exception of ammonium compounds and sulphites. Einecs | 232-435-9 Description | Dark brown to black liquids or solids Purity Colour bound by DEAE cellulose | Not more than 50 % Colour bound by phosphoryl cellulose | Not more than 50 % Colour intensity (1) | 0,01-0,12 Total nitrogen | Not more than 0,1 % Total sulphur | Not more than 0,2 % Arsenic | Not more than 1 mg/kg Lead | Not more than 2 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 25 mg/kg E 150b CAUSTIC SULPHITE CARAMEL Definition | Caustic sulphite caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of sulphite compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite and sodium bisulphite); no ammonium compounds are used. Einecs | 232-435-9 Description | Dark brown to black liquids or solids Purity Colour bound by DEAE cellulose | More than 50 % Colour intensity (1) | 0,05-0,13 Total nitrogen | Not more than 0,3 % (2) Sulphur dioxide | Not more than 0,2 % (2) Total sulphur | 0,3-3,5 % (2) Sulphur bound by DEAE cellulose | More than 40 % Absorbance ratio of colour bound by DEAE cellulose | 19-34 Absorbance ratio (A 280/560) | Greater than 50 Arsenic | Not more than 1 mg/kg Lead | Not more than 2 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 25 mg/kg E 150c AMMONIA CARAMEL Definition | Ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of ammonium compounds (ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate and ammonium phosphate); no sulphite compounds are used. Einecs | 232-435-9 Description | Dark brown to black liquids or solids Purity Colour bound by DEAE cellulose | Not more than 50 % Colour bound by phosphoryl cellulose | More than 50 % Colour intensity (1) | 0,08-0,36 Ammoniacal nitrogen | Not more than 0,3 % (2) 4-methylimidazole | Not more than 250 mg/kg (2) 2-acetyl-4-tetrahydroxy-butylimidazole | Not more than 10 mg/kg (2) Total sulphur | Not more than 0,2 % (2) Total nitrogen | 0,7-3,3 % (2) Absorbance ratio of colour bound by phosphoryl cellulose | 13-35 Arsenic | Not more than 1 mg/kg Lead | Not more than 2 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 25 mg/kg E 150d SULPHITE AMMONIA CARAMEL Definition | Sulphite ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof (e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis in the presence of both sulphite and ammonium compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite, sodium bisulphite, ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate, ammonium phosphate, ammonium sulphate, ammonium sulphite and ammonium hydrogen sulphite). Einecs | 232-435-9 Description | Dark brown to black liquids or solids Purity Colour bound by DEAE cellulose | More than 50 % Colour intensity (1) | 0,10-0,60 Ammoniacal nitrogen | Not more than 0,6 % (2) Sulphur dioxide | Not more than 0,2 % (2) 4-methylimidazole | Not more than 250 mg/kg (2) Total nitrogen | 0,3-1,7 % (2) Total sulphur | 0,8-2,5 % (2) Nitrogen/sulphur ratio of alcohol precipitate | 0,7-2,7 Absorbance ratio of alcohol precipitate (3) | 8-14 Absorbance ratio (A 280/560) | Not more than 50 Arsenic | Not more than 1 mg/kg Lead | Not more than 2 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 25 mg/kg E 151 BRILLIANT BLACK BN, BLACK PN Synonyms | CI Food Black 1 Definition | Brilliant Black BN consists essentially of tetrasodium-4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Brilliant Black BN is described as the sodium salt. The calcium and the potassium salt are also permitted. Class | Bisazo Colour Index No | 28440 Einecs | 219-746-5 Chemical names | Tetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate Chemical formula | C28H17N5Na4O14S4 Molecular weight | 867,69 Assay | Content not less than 80 % total colouring matters calculated as the sodium salt E1 cm 1 % 530 at ca 570 nm in solution Description | Black powder or granules Identification | A. | Spectrometry ---|--- Maximum in water at ca 570 nm | B. | Black-bluish solution in water ---|--- Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Not more than 10 % (expressed on the dye content) Organic compounds other than colouring matters:

| | | 4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid ---|--- | 4-amino-5-hydroxynaphthalene-1,7-disulfonic acid ---|--- | 8-aminonaphthalene-2-sulfonic acid ---|--- | 4,4′-diazoaminodi-(benzenesulfonic acid) ---|--- Total not more than 0,8 % Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) Ether extractable matter | Not more than 0,2 % under neutral conditions Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 153 VEGETABLE CARBON Synonyms | Vegetable black Definition | Vegetable carbon is produced by the carbonization of vegetable material such as wood, cellulose residues, peat and coconut and other shells. The raw material is carbonised at high temperatures. It consists essentially of finely divided carbon. It may contain minor amounts of nitrogen, hydrogen and oxygen. Some moisture may be absorbed on the product after manufacture. Colour Index No | 77266 Einecs | 215-609-9 Chemical names | Carbon Chemical formula | C Molecular weight | 12,01 Assay | Content not less than 95 % of carbon calculated on an anhydrous and ash-free basis Description | Black powder, odourless and tasteless Identification | A. | Solubility ---|--- Insoluble in water and organic solvents | B. | Burning ---|--- When heated to redness it burns slowly without a flame Purity Ash (Total) | Not more than 4,0 % (ignition temperature: 625 °C) Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg Polyaromatic hydrocarbons | The extract obtained by extraction of 1 g of the product with 10 g pure cyclohexane in a continuous extraction apparatus shall be colourless, and the fluorescence of the extract in ultraviolet light shall not be more intense than that of a solution of 0,100 mg of quinine sulfate in 1 000 ml of 0,01 M sulphuric acid. Loss on drying | Not more than 12 % (120 °C, 4 hrs) Alkali soluble matter | The filtrate obtained by boiling 2 g of the sample with 20 ml N sodium hydroxide and filtering shall be colourless E 154 BROWN FK Synonyms | CI Food Brown 1 Definition | Brown FK consists essentially of a mixture of: | I | sodium 4-(2,4-diaminophenylazo) benzenesulfonate ---|--- II | sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate ---|--- III | disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate) ---|--- IV | disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate) ---|--- V | disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate) ---|--- VI | trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate) ---|--- and subsidiary colouring matters together with water, sodium chloride and/or sodium sulfate as the principal uncoloured components. Brown FK is described as the sodium salt. The calcium and the potassium salt are also permitted. Class | Azo (a mixture of mono-, bis- and trisazo colours) Einecs | Chemical names | A mixture of: | I | sodium 4-(2,4-diaminophenylazo) benzenesulfonate ---|--- II | sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate ---|--- III | disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate) ---|--- IV | disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate) ---|--- V | disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate) ---|--- VI | trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate) ---|--- Chemical formula | | I | C12H11N4NaO3S ---|--- II | C13H13N4NaO3S ---|--- III | C18H14N6Na2O6S2 ---|--- IV | C18H14N6Na2O6S2 ---|--- V | C19H16N6Na2O6S2 ---|--- VI | C24H17N8Na3O9S3 ---|--- Molecular weight | | I | 314,30 ---|--- II | 328,33 ---|--- III | 520,46 ---|--- IV | 520,46 ---|--- V | 534,47 ---|--- VI | 726,59 ---|--- Assay | Content not less than 70 % total colouring matters Of the total colouring matters present the proportions of the components shall not exceed: | I | 26 % ---|--- II | 17 % ---|--- III | 17 % ---|--- IV | 16 % ---|--- V | 20 % ---|--- VI | 16 % ---|--- Description | Red-brown powder or granules Identification Orange to reddish solution | Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Not more than 3,5 % Organic compounds other than colouring matters: | 4-aminobenzene-1-sulfonic acid | Not more than 0,7 % m-phenylenediamine and 4-methyl-m-phenylenediamine | Not more than 0,35 % Unsulfonated primary aromatic amines other than m-phenylene diamine and 4-methyl-m-phenylene diamine | Not more than 0,007 % (calculated as aniline) Ether extractable matter | From a solution of pH 7, not more than 0,2 % Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 155 BROWN HT Synonyms | CI Food Brown 3 Definition | Brown HT consists essentially of disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo) di (naphthalene-1-sulfonate) and subsidiary colouring matters together with sodium chloride and/or sulfate as the principal uncoloured components. Brown HT is described as the sodium salt. The calcium and potassium salt are also permitted. Class | Bisazo Colour Index No | 20285 Einecs | 224-924-0 Chemical names | Disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo)di (naphthalene-1-sulfonate) Chemical formula | C27H18N4Na2O9S2 Molecular Weight | 652,57 Assay | Content not less than 70 % total colouring matters calculated as the sodium salt. E1 cm 1 % 403 at ca 460 nm in aqueous solution at pH 7 Description | Reddish-brown powder or granules Identification | A. | Spectrometry ---|--- Maximum in water of pH 7 at ca 460 nm | B. | Brown solution in water ---|--- Purity Water insoluble matter | Not more than 0,2 % Subsidiary colouring matters | Not more than 10 % (TLC method) Organic compounds other than colouring matters: | 4-aminonaphthalene-1-sulfonic acid | Not more than 0,7 % Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) Ether extractable matter | Not more than 0,2 % in a solution of pH 7 Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 160a (i) MIXED CAROTENES 1\. Plant carotenes Synonyms | CI Food Orange 5 Definition | Mixed carotenes are obtained by solvent extraction of natural strains of edible plants, carrots, vegetable oils, grass, alfalfa (lucerne) and nettle. The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha, gamma-carotene and other pigments may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material. Only the following solvents may be used in the extraction: acetone, methyl ethyl ketone, methanol, ethanol, propan-2-ol, hexane (4), dichloromethane and carbon dioxide. Class | Carotenoid Colour Index No | 75130 Einecs | 230-636-6 Chemical formula | Beta-carotene: C40H56 Molecular weight | Beta-carotene: 536,88 Assay | Content of carotenes (calculated as beta-carotene) is not less than 5 %. For products obtained by extraction of vegetables oils: not less than 0,2 % in edible fats. E1 cm 1 %2 500 at approximately 440 nm to 457 nm in cyclohexane Identification Spectrometry | Maximum in cyclohexane at 440 nm to 457 nm and 470 nm to 486 nm Purity Solvent residues | Acetone Methyl ethyl ketone Methanol Propan-2-ol Hexane Ethanol | Not more than 50 mg/kg, singly or in combination Dichloromethane: Not more than 10 mg/kg Lead | Not more than 5 mg/kg 2\. Algal carotenes Synonyms | CI Food Orange 5 Definition | Mixed carotenes may also be produced from natural strains of the algae Dunaliella salina, grown in large saline lakes located in Whyalla, South Australia. Beta-carotene is extracted using an essential oil. The preparation is a 20 to 30 % suspension in edible oil. The ratio of trans-cis isomers is in the range of 50/50 to 71/29. The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha-carotene, lutein, zeaxanthin and beta-cryptoxanthin may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material. Class | Carotenoid Colour Index No | 75130 Chemical formula | Beta-Carotene: C40H56 Molecular weight | Beta-Carotene: 536,88 Assay | Content of carotenes (calculated as beta-carotene) is not less than 20 % E1 cm 1 %2 500 at approximately by 440 nm to 457 nm in cyclohexane Identification Spectrometry | Maximum in cyclohexane at 440 nm to 457 nm and 474 nm to 486 nm Purity Natural tocopherols in edible oil | Not more than 0,3 % Lead | Not more than 5 mg/kg E 160a (ii) BETA-CAROTENE 1\. Beta-carotene Synonyms | CI Food Orange 5 Definition | These specifications apply predominantly to all trans isomer of beta-carotene together with minor amounts of other carotenoids. Diluted and stabilised preparations may have different trans-cis isomer ratios. Class | Carotenoid Colour Index No | 40800 Einecs | 230-636-6 Chemical names | Beta-carotene, beta, beta-carotene Chemical formula | C40H56 Molecular weight | 536,88 Assay | Not less than 96 % total colouring matters (expressed as beta-carotene) E1 cm 1 %2 500 at approximately by 440 nm to 457 nm in cyclohexane Description | Red to brownish-red crystals or crystalline powder Identification Spectrometry | Maximum in cyclohexane at 453 nm to 456 nm Purity Sulfated ash | Not more than 0,2 % Subsidiary colouring matters | Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters Lead | Not more than 2 mg/kg 2\. Beta-carotene from Blakeslea trispora Synonyms | CI Food Orange 5 Definition | Obtained by a fermentation process using a mixed culture of the two sexual mating types (+) and (–) of natural strains of the fungus Blakeslea trispora. The beta-carotene is extracted from the biomass with ethyl acetate, or isobutyl acetate followed by isopropyl alcohol, and crystallised. The crystallised product consists mainly of trans beta-carotene. Because of the natural process approximately 3 % of the product consists of mixed carotenoids, which is specific for the product. Class | Carotenoid Colour Index No | 40800 Einecs | 230-636-6 Chemical names | Beta-carotene, beta,beta-carotene Chemical formula | C40H56 Molecular weight | 536,88 Assay | Not less than 96 % total colouring matters (expressed as beta-carotene) E1 cm 1 %2 500 at approximately 440 nm to 457 nm in cyclohexane Description | Red, brownish-red or purple-violet crystals or crystalline powder (colour varies according to extraction solvent used and conditions of crystallisation) Identification Spectrometry | Maximum in cyclohexane at 453 nm to 456 nm Purity Solvent residues | Ethyl acetate Ethanol | Not more than 0,8 %, singly or in combination Isobutyl acetate: Not more than 1,0 % Isopropyl alcohol: Not more than 0,1 % Sulfated ash | Not more than 0,2 % Subsidiary colouring matters | Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters Lead | Not more than 2 mg/kg Mycotoxins: Aflatoxin B1 | Absent Trichothecene (T2) | Absent Ochratoxin | Absent Zearalenone | Absent Microbiology: Moulds | Not more than 100/g Yeasts | Not more than 100/g Salmonella | Absent in 25 g Escherichia coli | Absent in 5 g E 160b ANNATTO, BIXIN, NORBIXIN Synonyms | CI Natural Orange 4 Definition Class | Carotenoid Colour Index No | 75120 Einecs | Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7 Chemical names | | Bixin | : | 6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate 6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate ---|---|--- Norbixin | : | 9′Cis-6,6′-diapocarotene-6,6′-dioic acid 9′-Trans-6,6′-diapocarotene-6,6′-dioic acid Chemical formula | | Bixin | : | C25H30O4 ---|---|--- Norbixin | : | C24H28O4 Molecular weight | | Bixin | : | 394,51 ---|---|--- Norbixin | : | 380,48 Description | Reddish-brown powder, suspension or solution Identification Spectrometry | | Bixin | : | maximum in chloroform at ca 502 nm ---|---|--- Norbixin | : | maximum in dilute KOH solution at ca 482 nm (i) Solvent extracted bixin and norbixin Definition | Bixin is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with one or more of the following solvents: acetone, methanol, hexane or dichloromethane, carbon dioxide followed by the removal of the solvent. Norbixin is prepared by hydrolysis by aqueous alkali of the extracted bixin. Bixin and norbixin may contain other materials extracted from the annatto seed. The bixin powder contains several coloured components, the major single one being bixin, which may be present in both cis- and trans- forms. Thermal degradation products of bixin may also be present. The norbixin powder contains the hydrolysis product of bixin, in the form of the sodium or potassium salts as the major colouring principle. Both cis- and trans-forms may be present. Assay | Content of bixin powders not less than 75 % total carotenoids calculated as bixin. Content of norbixin powders not less than 25 % total carotenoids calculated as norbixin | Bixin | : | E1 cm 1 %2 870 at ca 502 nm in chloroform ---|---|--- Norbixin | : | E1 cm 1 %2 870 at ca 482 nm in KOH solution Purity Solvent residues | Acetone Methanol Hexane | not more than 50 mg/kg, singly or in combination Dichloromethane: not more than 10 mg/kg Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg (ii) Alkali extracted annatto Definition | Water soluble annatto is prepared by extraction with aqueous alkali (sodium or potassium hydroxide) of the outer coating of the seeds of the annatto tree (Bixa orellana L.) Water soluble annatto contains norbixin, the hydrolysis product of bixin, in the form of the sodium or potassium salts, as the major colouring principle. Both cis- and trans- forms may be present. Assay | Contains not less than 0,1 % of total carotenoids expressed as norbixin | Norbixin | : | E1 cm 1 %2 870 at ca 482 nm in KOH solution ---|---|--- Purity Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg (iii) Oil extracted annatto Definition | Annatto extracts in oil, as solution or suspension, are prepared by extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with edible vegetable oil. Annatto extract in oil contains several coloured components, the major single one being bixin, which may be present in both cis- and transforms. Thermal degradation products of bixin may also be present. Assay | Contains not less than 0,1 % of total carotenoids expressed as bixin | Bixin | : | E1 cm 1 %2 870 at ca 502 nm in chloroform ---|---|--- Purity Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 160c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN Synonyms | Paprika Oleoresin Definition | Paprika extract is obtained by solvent extraction of the natural strains of paprika, which consists of the ground fruits pods, with or without seeds, of Capsicum annuum L., and contains the major colouring principles of this spice. The major colouring principles are capsanthin and capsorubin. A wide variety of other coloured compounds is known to be present. Only the following solvents may be used in the extraction: methanol, ethanol, acetone, hexane, dichloromethane, ethyl acetate and carbon dioxide. Class | Carotenoid Einecs | Capsanthin: 207-364-1, capsorubin: 207-425-2 Chemical names | Capsanthin: (3R, 3′S, 5′R)-3,3′-dihydroxy-β,k-carotene-6-one Capsorubin: (3S, 3′S, 5R, 5R′)-3,3′-dihydroxy-k,k-carotene-6,6′-dione Chemical formula | Capsanthin: C40H56O3 Capsorubin: C40H56O4 Molecular weight | Capsanthin: 584,85 Capsorubin: 600,85 Assay | Paprika extract: content not less than 7,0 % carotenoids Capsanthin/capsorubin: not less than 30 % of total carotenoids E1 cm 1 %2 100 at ca 462 nm in acetone Description | Dark-red viscous liquid Identification | A. | Spectrometry ---|--- Maximum in acetone at ca 462 nm | B. | Colour reaction ---|--- A deep blue colour is produced by adding one drop of sulfuric acid to one drop of sample in 2-3 drops of chloroform Purity Solvent residues | Ethyl acetate Methanol Ethanol Acetone Hexane | Not more than 50 mg/kg, singly or in combination Dichloromethane: not more than 10 mg/kg Capsaicin | Not more than 250 mg/kg Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 160d LYCOPENE Synonyms | Natural Yellow 27 Definition | Lycopene is obtained by solvent extraction of the natural strains of red tomatoes (Lycopersicon esculentum L.) with subsequent removal of the solvent. Only the following solvents may be used: dichloromethane, carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol, hexane. The major colouring principle of tomatoes is lycopene, minor amounts of other carotenoid pigments may be present. Beside the other colour pigments the product may contain oils, fats, waxes, and flavour components naturally occurring in tomatoes. Class | Carotenoid Colour Index No | 75125 Chemical names | Lycopene, ψ,ψ-carotene Chemical formula | C40H56 Molecular weight | 536,85 Assay | Content not less than 5 % total colouring matters E1 cm 1 %3 450 at ca 472 nm in hexane Description | Dark red viscous liquid Identification Spectrometry | Maximum in hexane at ca 472 nm Purity Solvent residues | Ethyl acetate Methanol Ethanol Acetone Hexane Propan-2-ol | Not more than 50 mg/kg, singly or in combination Dichloromethane: not more than 10 mg/kg Sulfated ash | Not more than 0,1 % Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 160e BETA-APO-8′-CAROTENAL (C30) Synonyms | CI Food Orange 6 Definition | These specifications apply to predominantly all trans isomer of β-apo-8′-carotenal together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from β-apo-8′-carotenal meeting these specifications and include solutions or suspensions of ß-apo-8′carotenal in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios. Class | Carotinoid Colour Index No | 40820 Einecs | 214-171-6 Chemical names | β-apo-8′-carotenal, Trans-β-apo-8′carotene-aldehyde Chemical formula | C30H40O Molecular weight | 416,65 Assay | Not less than 96 % of total colouring matters E1 cm 1 %2 640 at ca 460-462 nm in cyclohexane Description | Dark violet crystals with metallic lustre or crystalline powder Identification Spectrometry | Maximum in cyclohexane at 460-462 nm Purity Sulfated ash | Not more than 0,1 % Subsidiary colouring matters | Carotenoids other than β-apo-8′-carotenal: not more than 3,0 % of total colouring matters Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 160f ETHYL ESTER OF BETA-APO-8′-CAROTENOIC ACID (C30) Synonyms | CI Food Orange 7, β-apo-8′-carotenoic ester Definition | These specifications apply to predominantly all trans isomer of β-apo-8′-carotenoic acid ethyl ester together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from β-apo-8′-carotenoic acid ethyl ester meeting these specifications and include solutions or suspensions of β-apo-8′-carotenoic acid ethyl ester in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios. Class | Carotenoid Colour Index No | 40825 Einecs | 214-173-7 Chemical names | β-apo-8′-carotenoic acid ethyl ester, ethyl 8′-apo-β-caroten-8′-oate Chemical formula | C32H44O2 Molecular weight | 460,70 Assay | Not less than 96 % of total colouring matters E1 cm 1 %2 550 at ca 449 nm in cyclohexane Description | Red to violet-red crystals or crystalline powder Identification Spectrometry | Maximum in cyclohexane at ca 449 nm Purity Sulfated ash | Not more than 0,1 % Subsidiary colouring matters | Carotenoids other than β-apo-8′-carotenoic acid ethyl ester: not more than 3,0 % of total colouring matters Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 161b LUTEIN Synonyms | Mixed Carotenoids, Xanthophylls Definition | Lutein is obtained by solvent extraction of the natural strains of edible fruits and plants, grass, lucerne (alfalfa) and tagetes erecta. The main colouring principle consists of carotenoids of which lutein and its fatty acid esters account for the major part. Variable amounts of carotenes will also be present. Lutein may contain fats, oils and waxes naturally occurring in the plant material. Only the following solvents may be used for the extraction: methanol, ethanol, propan-2-ol, hexane, acetone, methyl ethyl ketone, dichloromethane and carbon dioxide Class | Carotenoid Einecs | 204-840-0 Chemical names | 3,3′-dihydroxy-d-carotene Chemical formula | C40H56O2 Molecular weight | 568,88 Assay | Content of total colouring matter not less than 4 % calculated as lutein E1 cm 1 %2 550 at ca 445 nm in chloroform/ethanol (10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10) Description | Dark, yellowish brown liquid Identification Spectrometry | Maximum in chloroform/ethanol (10 + 90) at ca 445 nm Purity Solvent residues | Acetone Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane | Not more than 50 mg/kg, singly or in combination Dichloromethane: not more than 10 mg/kg Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 161g CANTHAXANTHIN Synonyms | CI Food Orange 8 Definition | These specifications apply to predominantly all trans isomers of canthaxanthin together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from canthaxanthin meeting these specifications and include solutions or suspensions of canthaxanthin in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios. Class | Carotinoid Colour Index No | 40850 Einecs | 208-187-2 Chemical names | β-Carotene-4,4′-dione, canthaxanthin, 4,4′-dioxo-β-carotene Chemical formula | C40H52O2 Molecular weight | 564,86 Assay | Not less than 96 % of total colouring matters (expressed as canthaxanthin) | E1 cm 1 %2 200 | at ca 485 nm in chloroform at 468-472 nm in cyclohexane at 464-467 nm in petroleum ether ---|--- Description | Deep violet crystals or crystalline powder Identification Spectrometry | Maximum in chloroform at ca 485 nm Maximum in cyclohexane at 468-472 nm Maximum in petroleum ether at 464-467 nm Purity Sulfated ash | Not more than 0,1 % Subsidiary colouring matters | Carotenoids other than canthaxanthin: not more than 5,0 % of total colouring matters Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 162 BEETROOT RED, BETANIN Synonyms | Beet Red Definition | Beet red is obtained from the roots of natural strains of red beets (Beta vulgaris L. var. rubra) by pressing crushed beet as press juice or by aqueous extraction of shredded beet roots and subsequent enrichment in the active principle. The colour is composed of different pigments all belonging to the class betalaine. The main colouring principle consists of betacyanins (red) of which betanin accounts for 75-95 %. Minor amounts of betaxanthin (yellow) and degradation products of betalaines (light brown) may be present. Besides the colour pigments the juice or extract consists of sugars, salts, and/or proteins naturally occurring in red beets. The solution may be concentrated and some products may be refined in order to remove most of the sugars, salts and proteins. Class | Betalaine Einecs | 231-628-5 Chemical names | (S-(R′,R′)-4-(2-(2-Carboxy-5(β-D-glucopyranosyloxy)-2,3-dihydro-6-hydroxy-1H-indol-1-yl)ethenyl)-2,3-dihydro-2,6-pyridine-dicarboxylic acid; 1-(2-(2,6-dicarboxy-1,2,3,4-tetrahydro-4-pyridylidene)ethylidene)-5-β-D-glucopyranosyloxy)-6-hydroxyindolium-2-carboxylate Chemical formula | Betanin: C24H26N2O13 Molecular weight | 550,48 Assay | Content of red colour (expressed as betanine) is not less than 0,4 % E1 cm 1 %1 120 at ca 535 nm in aqueous solution at pH 5 Description | Red or dark red liquid, paste, powder or solid Identification Spectrometry | Maximum in water of pH 5 at ca 535 nm Purity Nitrate | Not more than 2 g nitrate anion/g of red colour (as calculated from assay). Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 163 ANTHOCYANINS Definition | Anthocyanins are obtained by extraction with sulphited water, acidified water, carbon dioxide, methanol or ethanol from the natural strains of vegetables and edible fruits. Anthocyanins contain common components of the source material, namely anthocyanine, organic acids, tannins, sugars, minerals etc., but not necessarily in the same proportions as found in the source material. Class | Anthocyanin Einecs | 208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437-0 (delphinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin) Chemical names | 3,3′,4′,5,7-Pentahydroxy-flavylium chloride (cyanidin) 3,4′,5,7-Tetrahydroxy-3′-methoxyflavylium chloride (peonidin) 3,4′,5,7-Tetrahydroxy-3′,5′-dimethoxyflavylium chloride (malvidin) 3,5,7-Trihydroxy-2-(3,4,5,trihydroxyphenyl)-1-benzopyrylium chloride (delphinidin) 3,3′4′,5,7-Pentahydroxy-5′-methoxyflavylium chloride (petunidin) 3,5,7-Trihydroxy-2-(4-hydroxyphenyl)-1-benzopyrilium chloride (pelargonidin) Chemical formula | Cyanidin: C15H11O6Cl Peonidin: C16H13O6Cl Malvidin: C17H15O7Cl Delphinidin: C15H11O7Cl Petunidin: C16H13O7Cl Pelargonidin: C15H11O5Cl Molecular weight | Cyanidin: 322,6 Peonidin: 336,7 Malvidin: 366,7 Delphinidin: 340,6 Petunidin: 352,7 Pelargonidin: 306,7 Assay | E1 cm 1 % 300 for the pure pigment at 515-535 nm at pH 3,0 Description | Purplish-red liquid, powder or paste, having a slight characteristic odour Identification Spectrometry | Maximum in methanol with 0,01 % conc. HCl Cyanidin: 535 nm Peonidin: 532 nm Malvidin: 542 nm Delphinidin: 546 nm Petunidin: 543 nm Pelargonidin: 530 nm Purity Solvent residues | Methanol Ethanol | Not more than 50 mg/kg, singly or in combination Sulfur dioxide | Not more than 1 000 mg/kg per percent pigment Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 170 CALCIUM CARBONATE Synonyms | CI Pigment White 18, Chalk Definition | Calcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions. Class | Inorganic Colour Index No | 77220 Einecs | Calcium carbonate: 207-439-9 Limestone: 215-279-6 Chemical names | Calcium carbonate Chemical formula | CaCO3 Molecular weight | 100,1 Assay | Content not less than 98 % on the anhydrous basis Description | White crystalline or amorphous, odourless and tasteless powder Identification Solubility | Practically insoluble in water and in alcohol. Dissolves with effervescence in diluted acetic acid, in diluted hydrochloric acid and in diluted nitric acid, and the resulting solutions, after boiling, give positive tests for calcium. Purity Loss on drying | Not more than 2,0 % (200 °C, 4 hours) Acid-insoluble substances | Not more than 0,2 % Magnesium and alkali salts | Not more than 1,5 % Fluoride | Not more than 50 mg/kg Antimony (as Sb) Copper (as Cu) Chromium (as Cr) Zinc (as Zn) Barium (as Ba) | Not more than 100 mg/kg, singly or in combination Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Cadmium | Not more than 1 mg/kg E 171 TITANIUM DIOXIDE Synonyms | CI Pigment White 6 Definition | Titanium dioxide consists essentially of pure anatase and/or rutile titanium dioxide which may be coated with small amounts of alumina and/or silica to improve the technological properties of the product. Class | Inorganic Colour Index No | 77891 Einecs | 236-675-5 Chemical names | Titanium dioxide Chemical formula | TiO2 Molecular weight | 79,88 Assay | Content not less than 99 % on an alumina and silica-free basis Description | White to slightly coloured powder Identification Solubility | Insoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulfuric acid. Purity Loss on drying | Not more than 0,5 % (105 °C, 3 hours) Loss on ignition | Not more than 1,0 % on a volatile matter free basis (800 °C) Aluminium oxide and/or silicon dioxide | Total not more than 2,0 % Matter soluble in 0,5 N HCl | Not more than 0,5 % on an alumina and silica-free basis and, in addition, for products containing alumina and/or silica, not more than 1,5 % on the basis of the product as sold. Water soluble matter | Not more than 0,5 % Cadmium | Not more than 1 mg/kg Antimony | Not more than 50 mg/kg by total dissolution Arsenic | Not more than 3 mg/kg by total dissolution Lead | Not more than 10 mg/kg by total dissolution Mercury | Not more than 1 mg/kg by total dissolution Zink | Not more than 50 mg/kg by total dissolution E 172 IRON OXIDES AND IRON HYDROXIDES Synonyms | | Iron Oxide Yellow | : | CI Pigment Yellow 42 and 43 ---|---|--- Iron Oxide Red | : | CI Pigment Red 101 and 102 Iron Oxide Black | : | CI Pigment Black 11 Definition | Iron oxides and iron hydroxides are produced synthetically and consist essentially of anhydrous and/or hydrated iron oxides. The range of hues includes yellows, reds, browns and blacks. Food quality iron oxides are primarily distinguished from technical grades by the comparatively low levels of contamination by other metals. This is achieved by the selection and control of the source of the iron and/or by the extent of chemical purification during the manufacturing process. Class | Inorganic Colour Index No | | Iron Oxide Yellow | : | 77492 ---|---|--- Iron Oxide Red | : | 77491 Iron Oxide Black | : | 77499 Einecs | | Iron Oxide Yellow | : | 257-098-5 ---|---|--- Iron Oxide Red | : | 215-168-2 Iron Oxide Black | : | 235-442-5 Chemical names | | Iron Oxide Yellow | : | hydrated ferric oxide, hydrated iron (III) oxide ---|---|--- Iron Oxide Red | : | anhydrous ferric oxide, anhydrous iron (III) oxide Iron Oxide Black | : | ferroso ferric oxide, iron (II, III) oxide Chemical formula | | Iron Oxide Yellow | : | FeO(OH)·H2O ---|---|--- Iron Oxide Red | : | Fe2O3 Iron Oxide Black | : | FeO·Fe2O3 Molecular weight | | 88,85 | : | FeO(OH) ---|---|--- 159,70 | : | Fe2O3 231,55 | : | FeO·Fe2O3 Assay | Yellow not less than 60 %, red and black not less than 68 % total iron, expressed as iron Description | Powder; yellow, red, brown or black in hue Identification Solubility | Insoluble in water and in organic solvents Soluble in concentrated mineral acids Purity Water soluble matter | Not more than 1,0 % | By total dissolution Arsenic | Not more than 5 mg/kg Barium | Not more than 50 mg/kg Cadmium | Not more than 5 mg/kg Chromium | Not more than 100 mg/kg Copper | Not more than 50 mg/kg Lead | Not more than 20 mg/kg Mercury | Not more than 1 mg/kg Nickel | Not more than 200 mg/kg Zinc | Not more than 100 mg/kg E 173 ALUMINIUM Synonyms | CI Pigment Metal, Al Definition | Aluminium powder is composed of finely divided particles of aluminium. The grinding may or may not be carried out in the presence of edible vegetable oils and/or food additive quality fatty acids. It is free from admixture with substances other than edible vegetable oils and/or food additive quality fatty acids. Colour Index No | 77000 Einecs | 231-072-3 Chemical names | Aluminium Chemical formula | Al Atomic weight | 26,98 Assay | Not less than 99 % calculated as Al on an oil-free basis Description | A silvery-grey powder or tiny sheets Identification Solubility | Insoluble in water and in organic solvents. Soluble in dilute hydrochloric acid. The resulting solution gives positive tests for aluminium. Purity Loss on drying | Not more than 0,5 % (105 °C, to constant weight) Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg E 174 SILVER Synonyms | Argentum, Ag Class | Inorganic Colour Index No | 77820 Einecs | 231-131-3 Chemical names | Silver Chemical formula | Ag Atomic weight | 107,87 Assay | Content not less than 99,5 % Ag Description | Silver-coloured powder or tiny sheets E 175 GOLD Synonyms | Pigment Metal 3, Aurum, Au Class | Inorganic Colour Index No | 77480 Einecs | 231-165-9 Chemical names | Gold Chemical formula | Au Atomic weight | 197,0 Assay | Content not less than 90 % Au Description | Gold-coloured powder or tiny sheets Purity Silver | Not more than 7,0 % | After complete dissolution Copper | Not more than 4,0 % E 180 LITHOLRUBINE BK Synonyms | CI Pigment Red 57, Rubinpigment, Carmine 6B Definition | Lithol Rubine BK consists essentially of calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalenecarboxylate and subsidiary colouring matters together with water, calcium chloride and/or calcium sulfate as the principal uncoloured components. Class | Monoazo Colour Index No | 15850:1 Einecs | 226-109-5 Chemical names | Calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalene-carboxylate Chemical formula | C18H12CaN2O6S Molecular weight | 424,45 Assay | Content not less than 90 % total colouring matters E1 cm 1 % 200 at ca 442 nm in dimethylformamide Description | Red powder Identification Spectrometry | Maximum in dimethylformamide at ca 442 nm Purity Subsidiary colouring matters | Not more than 0,5 % Organic compounds other than colouring matters: | 2-Amino-5-methylbenzenesulfonic acid, calcium salt | Not more than 0,2 % 3-hydroxy-2-naphthalenecarboxylic acid, calcium salt | Not more than 0,4 % Unsulfonated primary aromatic amines | Not more than 0,01 % (expressed as aniline) Ether extractable matter | From a solution of pH 7, not more than 0,2 % Arsenic | Not more than 3 mg/kg Lead | Not more than 10 mg/kg Mercury | Not more than 1 mg/kg Cadmium | Not more than 1 mg/kg Heavy metals (as Pb) | Not more than 40 mg/kg * * * (1) Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm. (2) Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units. (3) Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided by the absorbance at 560 nm (1 cm cell). (4) Benzene not more than 0,05 % v/v. * * * ANNEX II PART A Repealed Directive with list of its successive amendments (referred to in Article 2) Commission Directive 95/45/EC | (OJ L 226, 22.9.1995, p. 1) ---|--- Commission Directive 1999/75/EC | (OJ L 206, 5.8.1999, p. 19) Commission Directive 2001/50/EC | (OJ L 190, 12.7.2001, p. 14) Commission Directive 2004/47/EC | (OJ L 113, 20.4.2004, p. 24) Commission Directive 2006/33/EC | (OJ L 82, 21.3.2006, p. 10) PART B List of time-limits for transposition into national law (referred to in Article 2) Directive | Time-limit for transposition ---|--- 95/45/EC | 1 July 1996 (1) 1999/75/EC | 1 July 2000 2001/50/EC | 29 June 2002 2004/47/EC | 1 April 2005 (2) 2006/33/EC | 10 April 2007 * * * (1) According to Article 2(2) of Directive 95/45/EC, products put on the market or labelled before 1 July 1996 which do not comply with that Directive may, however, be marketed until stocks are exhausted. (2) According to Article 3 of Directive 2004/47/EC, products on the market or labelled before 1 April 2005 which do not comply with that Directive may be marketed until stocks are exhausted. * * * ANNEX III Correlation table Directive 95/45/EC | This Directive ---|--- Article 1, first paragraph | Article 1 Article 1, second paragraph | — Article 2 | — — | Article 2 Article 3 | Article 3 Article 4 | Article 4 Annex | Annex I — | Annex II — | Annex III * * *